An interventional study of PerClot and Floseal, Surgicel, Surgiflo, Arista in Endometriosis, Ovarian Cyst and Menorrhagia, sponsored by CryoLife Europa. Completed at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-01.
Sponsored by CryoLife Europa · Not applicable, Interventional, and Treatment
This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care. PerClot is a CE marked device and is currently used as a haemostat in gynaecological surgery throughout Europe. The purpose of this study is to collect additional post market data on its use in this indication.
This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care.
All subjects in this randomized study will undergo a laparoscopic or open gynecological procedure such as hysterectomy, cystectomy, myomectomy, endometrial excision or ablation. Subjects will be randomized to receive PerClot or usual care.
This research will utilize a multi-center, prospective, randomized controlled study. The study will be conducted in2 study sites in Europe. An assumed sample of 90 subjects will be enrolled to evaluate the time to haemostasis. The enrollment of subjects to receive treatment will be based upon specific inclusion and exclusion criteria. Subjects will be randomized on a 1:1 basis to receive either PerClot or usual care. Data collected from both arms will be compared.
Usual care will be at the discretion of the surgeon and may include any other haemostat or diathermy/electrocautery.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 90 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →CryoLife Europa is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subject with a history of pelvic or abdominal radiotherapy (within 8 weeks)
PerClot® Polysaccharide Hemostatic System (PerClot) is a medical device composed of absorbable polysaccharide particles (AMPs) and delivery applicators. Investigators will have the option to choose 3g or 5g dependent on the requirements of the patient
Device: PerClot
Usual care will consist of any other haemostat the Investigator would normally use in the control of bleeding i.e arista, Floseal, surgical, surgiflo. If the Investigator would not normally use a haemostat to control bleeding then electrocautery or diathermy may be used in this arm
Device: Floseal, Surgicel, Surgiflo, Arista · Procedure: Electrocautery/Diatermy
Haemostatic device for the control of bleeding from capillary, venous or arteriolar vessels by pressure, ligature or other conventional means is either ineffective or impractical.
Haemostatic device for the control of bleeding
Procedure for the control of bleeding
achievement of haemostasis (yes/no).
visual observation of cessation of bleeding
Time frame: measured up to 10 minutes after application
Absence of re-intervention for post-operative bleeding
No return to OR for bleeding
Time frame: within 30 days of initial surgery
Absence of proven infection
No positive culture of blood results which indicate infection
Time frame: within 30 days of initial surgery
Absence of bleeding related adverse events
No adverse events which are specifically caused by bleeding
Time frame: within 30 days of initial surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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CryoLife Europa